Navigating complex regulations in different geographies can be daunting. Our team of regulatory experts can support you in multiple areas including
- guidance for dossier preparation and registration to various regulatory agencies worldwide in CTD, ACTD and other formats
- assistance to prepare DMFs for submission to the US FDA
- help to prepare and file ANDA documents
- respond to queries from regulatory agency across the globe
- gap analysis of your dossiers and solutions
- training for QA and manufacturing staff to handle regulatory inspections as well as QA/QC training
- update documentation and QA systems to the highest regulatory standards
- dry audit runs before regulatory inspections and customer audits
- regular internal audits
- documentation assistance including – Quality Manual, Master Validation Plan, SOPs, BMR/BPR, Quality Review, QA reports
- batch recall guidance
- post-market surveillance
- PSUR reports
Audit runs and training exercises are conducted by our experienced auditors. They have been approved and certified by Forum Auditorias, Europe.
Our clients include pharma and biotech companies and investors.